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NCT05307458
Evaluating the Pharmacokinetics and Patient Outcomes of Buprenorphine Microdosing
trial testing Buprenorphine/naloxone in Opioid Use Disorder in 20 participants. Status unknown.
30 June 2024
Quick facts
| Lead sponsor | United Health Services Hospitals, Inc. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 20 |
| Start date | 1 July 2022 |
| Primary completion | 30 June 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Buprenorphine/naloxone
Conditions studied
- Opioid Use Disorder — all drugs for Opioid Use Disorder →
- Opioid Withdrawal — all drugs for Opioid Withdrawal →
Sponsor
United Health Services Hospitals, Inc.
Who can join
18 and older, any sex, with Opioid Use Disorder or Opioid Withdrawal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
There are more than 2.1 million people in the United States with opioid use disorder, and according to preliminary data from the US Centers for Disease Control and Prevention opioid overdose deaths rose 36% to more than 69,000 deaths in 2020. Treatment with buprenorphine or methadone reduces overdose deaths in patients with opioid use disorder. However, most patients with opioid use disorder do not receive treatment. In addition to the rising rates of morbidity and mortality, the healthcare, social, and societal costs of the opioid epidemic are roughly one trillion dollars annually. Rapidly scalable strategies are needed to increase access to treatment and improve treatment retention. The investigators propose a novel buprenorphine micro-dosing study to evaluate the pharmacokinetics, treatment retention, and qualitative outcomes in participants transitioning from methadone maintenance therapy to buprenorphine using a micro-dosing initiation in the outpatient setting. The proposed study will report participant pharmacokinetics, treatment retention, Clinical Opiate Withdrawal Scale (COWS) score, Treatment Satisfaction Questionnaire for Medication (TSQM) score, and other qualitative outcomes.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Initiating buprenorphine to treat opioid use disorder without prerequisite withdrawal: an updated systematic review.
Adams KK, Waters K, Sobieraj DM. · · 2025 · cited 8× · PMID 39980050 · DOI 10.1186/s13722-025-00548-z
Verify or expand the search:
- PubMed search for NCT05307458
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Buprenorphine/naloxone
Trials testing the same drug.
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- NCT04480554 — Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1 · Phase 2 · terminated
- NCT04794790 — Buprenorphine Induction for Fentanyl Dependent Opioid Users · EARLY_PHASE1 · withdrawn
- NCT03580902 — CBT4CBT for Office Based Buprenorphine · Phase 1, PHASE2 · completed
- NCT03740243 — Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology · Phase 4 · withdrawn
Other recruiting trials for Opioid Use Disorder
Currently open trials in the same condition.
- NCT07278518 — Evaluation of a Patient Decision Aid for Emergency Department Initiated Buprenorphine · NA · recruiting
- NCT07044466 — Social Functioning in Opioid Use Disorder · NA · recruiting
- NCT07158853 — Combined tDCS and Cognitive Training as an Adjunctive Treatment in Opioid Use Disorder · NA · recruiting
- NCT06943859 — Ketamine for Opioid Use Disorder · Phase 2 · recruiting
- NCT06651177 — Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder · Phase 2 · recruiting
Other United Health Services Hospitals, Inc. trials
Trials by the same sponsor.
- NCT05336968 — Triamcinolone Ketorolac (TriKe) Knee Trial · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05307458 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by United Health Services Hospitals, Inc.
- Last refreshed: 26 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05307458.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing